This document is intended to provide guidance in order to facilitate harmonised approvals of quality systems of manufacturers for application of module D or of module H1 of MID. As the conformity to EN ISO 9001: 2000 appears to-day the most appropriate generic standard in order to give presumption of conformity, this document is built according to the structure of this standard. Only the titles of this standard are referred in.

AUTHORED BY: Working Group 8

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